The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Customcornea Measurement Device (ccmd).
| Device ID | K000637 |
| 510k Number | K000637 |
| Device Name: | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) |
| Classification | Aberrometer, Ophthalmic |
| Applicant | ALCON LABORATORIES, INC. 2800 DISCOVERY DR., Orlando, FL 32826 -3714 |
| Contact | S.k. Mcgarvey |
| Correspondent | S.k. Mcgarvey ALCON LABORATORIES, INC. 2800 DISCOVERY DR., Orlando, FL 32826 -3714 |
| Product Code | NCF |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-05-19 |